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Active, Not Recruiting

NCT Number: NCT05150561

Muscle Dysfunction in Patients With Haematological Diseases

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hematologic Diseases Acute Lymphoid Leukemia Acute Myeloid Leukemia Bone Marrow Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

Some patients diagnosed with malignant hematological diseases are faced with poor prognosis and thus must undergo a demanding course of treatment associated with severe deconditioning potentially leading to worse prognostic outcomes. It is currently not well-described, to what extend patients body composition at the point of diagnoses should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

Exclusion criteria

  • Age: <18
  • Pregnancy
  • Physical or mental disabilities precluding test of muscle function
  • Inability to read and understand Danish.

Treatment and study plan

Primary outcomes

  1. Change in Whole body Lean body Mass

    Time frame: Baseline and 6 months after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

Secondary outcomes

  1. Hospitalization duration

    Time frame: 1 year post treatment

    Total number days in hospital

  2. Disease free survival

    Time frame: 1 year post treatment

    Risk of disease progression

  3. Overall survival

    Time frame: 1 year post treatment

    Risk of mortality from any-cause

  4. Change in appendicular lean mass

    Time frame: Baseline and 6 after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

  5. Change in whole body fat percentage

    Time frame: Baseline and 6 months after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

  6. Change in visceral fat mass

    Time frame: Baseline and 6 months after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

  7. Change in bone mineral density

    Time frame: Baseline and 6 months after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

  8. Change in bone mineral content

    Time frame: Baseline and 6 months after treatment start

    Dual-energy X-ray Absorptiometry (DXA) scan

  9. Change in walking capacity

    Time frame: Baseline and 6 months after treatment start

    Maximum 10 meter walking speed

  10. Change in lower body physical function

    Time frame: Baseline and 6 months after treatment start

    30 seconds Sit-To-Stand test

  11. Change in maximum leg power

    Time frame: Baseline and 6 months after treatment start

    Leg extensor power test (Nottingham Power Rig)

  12. Change in hand grip strength

    Time frame: Baseline and 6 months after treatment start

    Maximum strength test by handgrip dynamometer

  13. Change in inflammation markers

    Time frame: Baseline and 6 months after treatment start

    Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they are inflammation markers.

  14. Change in creatinine

    Time frame: Baseline and 6 months after treatment start

    Blood values are registered from the patients hospital record in relation to assessments. Creatinine is registered due to their relation to muscle strength..

  15. Change in hemoglobin

    Time frame: Baseline and 6 months after treatment start

    Blood values are registered from the patients hospital record in relation to assessments. Hemoglobin is registered due to their relation to muscle strength.

  16. Change in body fat percentage

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  17. Change in fat mass

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  18. Change in fat-free mass

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  19. Change in muscle mass

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  20. Change in bone mass

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  21. Change in total body water

    Time frame: Baseline and 6 months after treatment start

    Bioelectrical Impedance Analyzer

  22. Change in health-related quality of life

    Time frame: Baseline and 6 months after treatment start

    European Organisation for Research and Treatment of Cancer Quality of LifeQuestionnaire, Version 3.0 Scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  23. Change in physical activity level

    Time frame: Baseline and 6 months after treatment start

    The International Physical Activity Questionnaires, short form. The Questionnaires covers the frequency and duration of vigorous, moderate, and walking activities over the last 7 days, as well as a single-item question on weekday sitting. Using the instrument's scoring protocol, total weekly physical activity can be calculated to three levels of physical activity and the interpretation of the questionnaire can be categorized in low, moderate and high physical activity, based on the stated time and Metabolic Equivalent of Task (METs min/week) used in different types of activities.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Prevalence and the Prognostic Value of Sarcopenia Among Patients With Haematological Cancer Diseases - A Prospective Observational Cohort Study.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2021
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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